Clinical Evaluation of Two Daily Disposable Contact Lenses

The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: delefilcon A; Device: narafilcon A

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom, BN1 1RH
  • London, United Kingdom, N2 8AG
  • London, United Kingdom, NW4 3FB
  • Norwich, United Kingdom, NR2 1PB
  • Bristol
    • Knowle, Bristol, United Kingdom, BS4 2AL
  • Hampshire
    • Portchester, Hampshire, United Kingdom, PO16 9UN
  • Herefordshire
    • Hay-on-Wye, Herefordshire, United Kingdom, HR3 5EQ
  • Herts
    • St. Albans, Herts, United Kingdom, AL1 3LH
  • Middlesex
    • Eastcote, Pinner, Middlesex, United Kingdom, HA5 1RJ
  • South Glamorgan
    • Cardiff, South Glamorgan, United Kingdom, CF24 3RQ
  • Surrey
    • Farnham, Surrey, United Kingdom, GU9 7EN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
4. The subject must be a current successful spherical soft contact lens wearer in both eyes.
5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
6. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.
7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
3. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
10. Amblyopia
11. Evidence of lid abnormality or infection (including blepharitis/meibomitis)
12. Conjunctival abnormality or infection.
13. Any active ocular disease.
14. Employee or family member of the staff of the investigational site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: delefilcon A; Spherical daily disposable soft contact lens	Device: delefilcon A; Daily disposable soft contact lens to be worn at least 8 hours daily; Other Names: DAILIES Total 1
Experimental: narafilcon A; Spherical daily disposable soft contact lens Class 1 UV blocking	Device: narafilcon A; Daily disposable contact lens to be worn at least 8 hours daily; Other Names: 1-Day ACUVUE TruEye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ease of Lens Removal	After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).	Day 7

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-5305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No